Request for Clinical Trial personnel as workers under Level-4 Essential Services.

May 18, 2020

 

 

Dear Members, 

 

SACRA has not received feedback from the powers that be regarding our request to be listed as an Essential Service. In order for us to clarify our situation, SACRA recommends that all sites and industry staff contact your Sponsor/employer for guidance on per-protocol management of study activities during the COVID lockdown period. This includes clinical trial sites that have enrolling studies, as well as CRAs. 

 

Sites / PIs should contact their Ethics Committee for guidance on recruitment of subjects onto your studies. Some Ethics Committees in South Africa have prohibited enrolment of subjects at this time. 

 

All stakeholders should refer to the SAHPRA POLICY ON CONDUCT OF CLINICAL TRIALS OF HEALTH PRODUCTS DURING THE CURRENT COVID-19 PANDEMIC which can be found at:

 

https://www.sahpra.org.za/wp-content/uploads/2020/03/SAHPRA-Clinical-Trials-Conduct-Communication_COVID_19_25-March-2020.pdf 

 

 

The situation requires on-going risk management, incorporating employee and their families’ wellbeing, subject safety, data integrity, logistical considerations as well as thorough resourcing capabilities. In light of this, best practises can only emerge as we gain experience and find new solutions on how best to proceed with our vital work.

 

Regards,

Teresa Scanes

SACRA Vice Chair

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